Senior Engineering Manager (Pharmaceutical Manufacturing)

Location: York, United States; onsite role.

Company

hirify.global's BioTechnique is a sterile injectable full-service CDMO providing formulation, compounding, fill-finish, and lyophilization services from IND applications through commercial-scale production.

What you will do

• Lead Validation Engineers and Process Engineers supporting sterile pharmaceutical manufacturing operations.
• Oversee startup, commissioning, qualification, validation, and continuous operation of process equipment, utilities, facility systems, processes, and related engineering systems.
• Plan and manage project timelines, budgets, resources, equipment startups, vendors, contractors, and cross-functional engineering activities.
• Execute and review validation lifecycle activities, including IQ/OQ/PQ, process validation, cleaning validation, documentation, revalidation, and Site Validation Master Plan activities in ACE® or Kneat Paperless Validation System.
• Support investigations, risk assessments, FMEA, root-cause analysis, CAPAs, audits, inspections, technical reports, system changes, and client-facing technical discussions.
• Drive process optimization, efficiency improvements, cost reduction, KPI-based continuous improvement, training, technology transfers, new product introductions, and collaboration with Quality Assurance, Manufacturing, Metrology, Facilities, MSAT, Supply Chain, overseas teams, clients, and regulatory stakeholders.

Requirements

• Bachelor’s degree or higher in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical field, or equivalent relevant experience.
• More than 10 years of pharmaceutical, biotechnology, or CDMO experience with leadership responsibility, preferably in a parenteral manufacturing environment involving aseptic or sterile manufacturing.
• Strong understanding of sterile injectable manufacturing, engineering systems, and validation lifecycle management.
• Working knowledge of quality systems and regulatory requirements, including 21 CFR Part 11/210/211, cGMPs, and pharmaceutical regulatory guidelines.
• Experience supporting FDA inspections, capital projects, equipment startups, and client-facing pharmaceutical operations.
• Strong innovation skills and the ability to foster continuous improvement.
• Ability to plan, organize, analyze, resolve problems, work independently, manage multiple projects, and remain resourceful and detail-oriented.

Culture & Benefits

• Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Employee assistance programs, basic life insurance, short- and long-term disability coverage, and related insurance options.
• 401(k) plan with matching, PTO, sick time, and paid holidays.
• Education assistance, pet insurance, fitness perks, and financial discounts.
• Incentive pay or a performance agreement may be included in the total compensation package.
• Work in a multicultural, globally operating organization focused on coaching, professional development, safety, and continuous improvement.